TrialBridgeNCT07135271
BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer
Recruiting · Not Applicable · University College, London · registry updated 2026-07-29
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The goal of this randomised clinical trial is to assess whether personalised treatment counselling can improve the decision-making experience in patients with a new diagnosis of localised prostate cancer. The main question it aims to answer is: • Does the Bespoke Decision Support tool reduce decisional conflict in those choosing between treatment options for localised prostate cancer? Researchers will compare the addition of the Bespoke Decision Support tool to standard treatment counselling versus standard counselling alone. Patient participants will: * Receive standard counselling with or without access to the Bespoke Decision Support tool (based on arm of randomisation), prior to making a treatment decision. * Answer to questionnaires regarding urinary, sexual and bowel function and decision-making outcomes before and after making a treatment decision and at 3, 6, and 12 months after initiating treatment. * Take part in a qualitative interview to discuss their decision-making experience Health Care Professional participants will: • Take part in a qualitative interview to discuss their experience in providing decision support in the trial using the Bespoke Decision Support tool.
Inclusion
- Inclusion Criteria for Patient-Participants:
- Newly diagnosed localised prostate cancer
- Clinically suitable for at least two of the following treatment options:
- active surveillance
- focal therapy
- radical prostatectomy
Exclusion
- Exclusion Criteria for Patient Participants:
- Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.
- Suspicion of metastatic prostate cancer based on clinical or imaging evidence including:
- Imaging identified suspicious lesion on bone scan, CT, whole-body MRI or PSMA-PET/CT;
- PSA ≥50 ng/mL.
- Not able to provide informed consent.